Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes

Lars Søndergaard; Josep Rodés-Cabau; Axel Hans-Peter Linke; Stephan Fichtlscherer; Ulrich Schäfer; Karl-Heinz Kuck; Joerg Kempfert; Dabit Arzamendi; Francesco Bedogni; Federico M Asch; Stephen Worthley; Francesco Maisano

doi:10.1016/j.jacc.2018.09.014

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes

Lars Søndergaard, Josep Rodés-Cabau, Axel Hans-Peter Linke, Stephan Fichtlscherer, Ulrich Schäfer, Karl-Heinz Kuck, Joerg Kempfert, Dabit Arzamendi, Francesco Bedogni, Federico M Asch, Stephen Worthley, Francesco Maisano

49 Citationer (Scopus)

Abstract

BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.

OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.

METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.

RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.

CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	72
Udgave nummer	23 Pt A
Sider (fra-til)	2859-2867
Antal sider	9
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2018.09.014
Status	Udgivet - 11 dec. 2018

Adgang til dokumentet

10.1016/j.jacc.2018.09.014

Citationsformater

Søndergaard, L., Rodés-Cabau, J., Hans-Peter Linke, A., Fichtlscherer, S., Schäfer, U., Kuck, K.-H., Kempfert, J., Arzamendi, D., Bedogni, F., Asch, F. M., Worthley, S., & Maisano, F. (2018). Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. Journal of the American College of Cardiology, 72(23 Pt A), 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. / Søndergaard, Lars; Rodés-Cabau, Josep; Hans-Peter Linke, Axel et al.
I: Journal of the American College of Cardiology, Bind 72, Nr. 23 Pt A, 11.12.2018, s. 2859-2867.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Søndergaard, L, Rodés-Cabau, J, Hans-Peter Linke, A, Fichtlscherer, S, Schäfer, U, Kuck, K-H, Kempfert, J, Arzamendi, D, Bedogni, F, Asch, FM, Worthley, S & Maisano, F 2018, 'Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes', Journal of the American College of Cardiology, bind 72, nr. 23 Pt A, s. 2859-2867. https://doi.org/10.1016/j.jacc.2018.09.014

@article{ec1ab3f4396242a8af15538c63c66aac,

title = "Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes",

abstract = "BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker na{\"i}ve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).",

author = "Lars S{\o}ndergaard and Josep Rod{\'e}s-Cabau and {Hans-Peter Linke}, Axel and Stephan Fichtlscherer and Ulrich Sch{\"a}fer and Karl-Heinz Kuck and Joerg Kempfert and Dabit Arzamendi and Francesco Bedogni and Asch, {Federico M} and Stephen Worthley and Francesco Maisano",

year = "2018",

month = dec,

day = "11",

doi = "10.1016/j.jacc.2018.09.014",

language = "English",

volume = "72",

pages = "2859--2867",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier Inc",

number = "23 Pt A",

}

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis

T2 - The PORTICO-I Trial 1-Year Outcomes

AU - Søndergaard, Lars

AU - Rodés-Cabau, Josep

AU - Hans-Peter Linke, Axel

AU - Fichtlscherer, Stephan

AU - Schäfer, Ulrich

AU - Kuck, Karl-Heinz

AU - Kempfert, Joerg

AU - Arzamendi, Dabit

AU - Bedogni, Francesco

AU - Asch, Federico M

AU - Worthley, Stephen

AU - Maisano, Francesco

PY - 2018/12/11

Y1 - 2018/12/11

N2 - BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

AB - BACKGROUND: The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk.OBJECTIVES: The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system.METHODS: This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated.RESULTS: A total of 941 patients (82.4 ± 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm2, respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naïve patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year.CONCLUSIONS: Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788).

U2 - 10.1016/j.jacc.2018.09.014

DO - 10.1016/j.jacc.2018.09.014

M3 - Journal article

C2 - 30261238

SN - 0735-1097

VL - 72

SP - 2859

EP - 2867

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 23 Pt A

ER -

Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes

Abstract

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